An interventional study of Arachidonic acid and Sunflower oil in Rabies Vaccination Reaction, sponsored by Tsinghua University. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Tsinghua University · Not applicable, Interventional, and Basic science
This study intends to use a randomized controlled trial design to vaccinate all participants against rabies and perform ARA interventions during vaccination to test the efficacy, safety, and intestinal flora of each group after immunization.
Rabies is an acute zoonotic infectious disease caused by central nervous system invasion by rabies virus. At present, there is still a lack of effective treatment, and once clinical symptoms appear, it is almost 100% fatal. Rabies vaccination within 24 hours of exposure may reduce the incidence of rabies. Pre-exposure prophylaxis is also effective, and the current recommended pre-exposure vaccination program in China is 0 days, 7th day, 21st days.
The health of the human body is inseparable from various nutrients. There are studies suggesting that arachidonic acid(ARA) has an immunomodulatory effect, but there is limited evidence for its effect on vaccines. Therefore, this study will explore the effects of nutritional supplements on the effectiveness of rabies vaccination.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's enrollment of 45 is below the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →Tsinghua University is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sunflower oil capsules
Dietary Supplement: Sunflower oil · Biological: Rabies Vaccine (Vero Cell) for Human Use
ARA capsules
Dietary Supplement: Arachidonic acid · Biological: Rabies Vaccine (Vero Cell) for Human Use
Sunflower oil capsules and ARA capsules
Dietary Supplement: Arachidonic acid · Dietary Supplement: Sunflower oil · Biological: Rabies Vaccine (Vero Cell) for Human Use
D3 ARA group will receive ARA capsules from the third day of the study. D6 ARA group will receive ARA capsules from the sixth day of the study
The placebo group and D6 ARA group will receive sunflower oil capsules from the third day of the study. D6 ARA group will stop receiving sunflower oil capsules from the fifth day of the study.
Every participant will receive three doses of rabies vaccination.
Changes of rabies virus antibody titers
specific antibody titers
Time frame: Day 6, 13, 16, 19, 26 of the study
Changes of neutralizing antibody titers
To test the ability of binding to rabies virus
Time frame: Day 6, 13, 16, 19, 26 of the study
serum blood fatty acid profiles
to test the change of fatty acid profiles after intervention
Time frame: Day 6, 13, 16，19 of the study
C-reactive protein
to test the potential C-reactive protein changes triggered by ARA supplementation
Time frame: Day 6, 13, 16 and 19 of the study
Routine analysis of intestinal flora: alpha diversity
The alpha diversity of microbiota in feces samples will be examined to explore the potential gut-immune response caused by intervention.
Time frame: Day 3 and day 19 of the study
Routine analysis of intestinal flora: beta diversity
The beta diversity of microbiota in feces samples will be examined to explore the potential gut-immune response caused by the intervention.
Time frame: Day 3 and day 19 of the study
Routine analysis of intestinal flora: species abundance histogram
The species abundance histogram of microbiota in feces samples will be examined to explore the potential gut-immune response caused by the intervention.
Time frame: Day 3 and day 19 of the study
Routine analysis of intestinal flora: Lefse
The Lefse of microbiota in feces samples will be conducted to explore the potential gut-immune response caused by the intervention.
Time frame: Day 3 and day 19 of the study
Routine analysis of intestinal flora: PLS-DA
The PLS-DA of microbiota in feces samples will be conducted to explore the potential gut-immune response caused by the intervention.
Time frame: Day 3 and day 19 of the study
Routine analysis of intestinal flora: KEGG pathway
The KEGG pathway microbiota in feces samples will be analyzed to explore the potential gut-immune response caused by the intervention.
Time frame: Day 3 and day 19 of the study
Routine analysis of intestinal flora: differential KO expression
The differential KO expression microbiota in feces samples will be analyzed to explore the potential gut-immune response caused by the intervention.
Time frame: Day 3 and day 19 of the study
Macrogenomic sequencing difference of intestinal flora
The macrogenomic sequencing analysis of microbiota in feces samples will be conducted to explore the potential gut-immune response caused by the intervention.
Time frame: Day 3 and day 19 of the study
Fecal fatty acid content
The fatty acid content in feces samples will be examined to explore the change of fatty acid intake caused by the intervention.
Time frame: Day 3 and day 19 of the study
Adverse events by ARA
To examine the safety of using ARA, including allergy, gastrointestinal discomfort and others.
Time frame: Day 3 to day 30 of the trial.
Serum triglyceride levels
To examine the changes of blood lipids in blood after intervention and evaluate the intervention safety. The spacific measurements include: Triglycerides (TG), high-density lipoprotein cholesterol (HDL-CHO), low-density lipoprotein cholesterol (LDL-C), and total cholesterol (TC).
Time frame: Days 3 and day 19 of the study.
Blood count: red blood cells
To evaluate the intervention safety.
Time frame: tested on day 3 and day 19 of the trial.
Blood count: white blood cells
To evaluate the intervention safety.
Time frame: tested on day 3 and day 19 of the trial.
Blood count: hemoglobin
To evaluate the intervention safety.
Time frame: tested on day 3 and day 19 of the trial.
Blood count: hematocrit
To evaluate the intervention safety.
Time frame: tested on day 3 and day 19 of the trial.
Blood count: platelets
To evaluate the intervention safety.
Time frame: tested on day 3 and day 19 of the trial.
Anxiety
Evaluated with General Anxiety Disorder-7 items. The scores are between 0 to 21, higher scores mean a worse outcome.
Time frame: tested on day 13 of the trial.
Depression
Evaluated with Patient Health Questionaire-9 items. The scores are between 0 to 27, higher scores mean a worse outcome.
Time frame: tested on day 13 of the trial.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2023 to primary completion in Jul 2023, 2 months.
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Arachidonic Acid · Sunflower Oil
Tsinghua University